FDA.report

Jones-FX Jones Fracture System

Primary DI
10815375021171
Brand
Jones-FX Jones Fracture System
Company
Restore Surgical LLC
Model
JC4535
Published
2015-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10815375021171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081537502117110815375021171

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
792932626
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10815375020020Mini Cannulated Titanium Headed and Headless Screw SetIC25122015-10-17
10815375020037Mini Cannulated Titanium Headed and Headless Screw SetIC25142015-10-17
10815375020044Mini Cannulated Titanium Headed and Headless Screw SetIC25162015-10-17
10815375020051Mini Cannulated Titanium Headed and Headless Screw SetIC25182015-10-17
10815375020068Mini Cannulated Titanium Headed and Headless Screw SetIC25202015-10-17
10815375020075Mini Cannulated Titanium Headed and Headless Screw SetIC25222015-10-17
10815375020082Mini Cannulated Titanium Headed and Headless Screw SetIC25242015-10-17
10815375020099Mini Cannulated Titanium Headed and Headless Screw SetIC25262015-10-17
10815375020105Mini Cannulated Titanium Headed and Headless Screw SetIC25282015-10-17
10815375020112Mini Cannulated Titanium Headed and Headless Screw SetIC25302015-10-17
10815375020129Mini Cannulated Titanium Headed and Headless Screw SetIC25322015-10-17
10815375020136Mini Cannulated Titanium Headed and Headless Screw SetIC25342015-10-17
10815375020143Mini Cannulated Titanium Headed and Headless Screw SetIC25362015-10-17
10815375020150Mini Cannulated Titanium Headed and Headless Screw SetIC25382015-10-17
10815375020167Mini Cannulated Titanium Headed and Headless Screw SetIC25402015-10-17
10815375020174Mini Cannulated Titanium Headed and Headless Screw SetIC30102015-10-17
10815375020181Mini Cannulated Titanium Headed and Headless Screw SetIC30122015-10-17
10815375020198Mini Cannulated Titanium Headed and Headless Screw SetIC30142015-10-17
10815375020204Mini Cannulated Titanium Headed and Headless Screw SetIC30162015-10-17
10815375020211Mini Cannulated Titanium Headed and Headless Screw SetIC30182015-10-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10